Pure Global

ALX BELOW ELBOW PROSTHESIS - EUDAMED Registration 05061081781047

Access comprehensive regulatory information for ALX BELOW ELBOW PROSTHESIS in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 05061081781047 and manufactured by Koalaa Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (ALX Cosmetic Hand Child, Left, Small 12), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
05061081781047
No
ALX BELOW ELBOW PROSTHESIS
Trade Name: ALX Cosmetic Hand Child, Left, Small 12
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y061809
Trade Name
ALX Cosmetic Hand Child, Left, Small 12
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05061081781047
Basic UDI
506108178ALXBE4X
Version Date
December 19, 2024
Manufacturer Last Update
November 25, 2024
Active Status
No
Manufacturer
Manufacturer Name
Koalaa Ltd
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
41-43 Standard Road London
Email
hi@yourkoalaa.com
Authorized Representative
SRN
IE-AR-000003999
Country
Ireland
Address
Stratton House, BISHOPSTOWN ROAD CORK
Email
tqmuk@aol.com
Telephone
+447545595464
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Belgium
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No